ID

14788

Beschreibung

Impact of a Surgical Sealing Patch on Lymphatic Drainage After ALND for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02311543

Link

https://clinicaltrials.gov/show/NCT02311543

Stichworte

Versionen (1)
  1. 28.04.16 28.04.16 -
Hochgeladen am

28. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02311543

Englisch

Eligibility Breast Cancer NCT02311543

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
at registration
Beschreibung

Registration

Datentyp

boolean

Alias
UMLS CUI [1]
C1514821
patient has given written informed consent before registration
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
female patients; eligible for primary alnd or sentinel lymph node procedure with frozen section and either:
Beschreibung

Gender | Excision of axillary lymph nodes | Sentinel Lymph Node Frozen Sections

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0193867
UMLS CUI [3,1]
C1522495
UMLS CUI [3,2]
C0016741
newly diagnosed
Beschreibung

Newly Diagnosed

Datentyp

boolean

Alias
UMLS CUI [1]
C1518321
or recurrent breast cancer in the conserved breast, chest wall or axilla
Beschreibung

Breast Carcinoma | Female breast | Entire chest wall | Axilla

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0222603
UMLS CUI [3]
C1279035
UMLS CUI [4]
C0004454
patients with histo- or cytology proven breast cancer uicc/ajcc stage i-iii
Beschreibung

Breast Carcinoma | UICC (tumor staging) | AJCC tumor staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0441914
UMLS CUI [3]
C0441915
age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
fluency in either german, french, italian, spanish, turkish or english
Beschreibung

Able to speak fluently German language | Able to speak fluently French language | Able to speak fluently Italian language | Able to speak fluently Spanish Language | Able to speak fluently Turkish language | Able to speak fluently English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0017477
UMLS CUI [2,1]
C0564241
UMLS CUI [2,2]
C0376246
UMLS CUI [3,1]
C0564241
UMLS CUI [3,2]
C0022275
UMLS CUI [4,1]
C0564241
UMLS CUI [4,2]
C0037750
UMLS CUI [5,1]
C0564241
UMLS CUI [5,2]
C0041402
UMLS CUI [6,1]
C0564241
UMLS CUI [6,2]
C0376245
the eq-5d questionnaire has been completed at registration
Beschreibung

EuroQoL five dimension questionnaire Complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2733251
UMLS CUI [1,2]
C0205197
patient with child-bearing potential, willing to use effective contraception, not currently pregnant and agreeing not to become pregnant after trial registration and during the 24 weeks after surgery
Beschreibung

Childbearing Potential Contraceptive methods | Pregnancy | Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0543467
a negative pregnancy test within 14 days prior to inclusion is available for all women with child-bearing potential
Beschreibung

Pregnancy test negative Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0427780
UMLS CUI [1,2]
C3831118
inclusion criteria at randomization
Beschreibung

Inclusion | Randomization

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0034656
alnd indicated according to clinical standards, either as single procedure or in combination with breast conserving surgery
Beschreibung

Excision of axillary lymph nodes Indicated | Breast-Conserving Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0193867
UMLS CUI [1,2]
C1444656
UMLS CUI [2]
C0917927
exclusion criteria at registration:
Beschreibung

Exclusion Criteria | Registration

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1514821
known hypersensitivity for tachosil® or fibrin sealant
Beschreibung

Hypersensitivity TachoSil | Hypersensitivity Fibrin Tissue Adhesive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1871272
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0016004
patients with mastectomy (simultaneously or within 1 month before registration); patients undergoing completion mastectomy at a later day will remain eligible and are evaluable for analysis according to intention to treat. if the axillary drain is still in place at the time of completion mastectomy and a separate drain is inserted underneath the skin flaps, only the axillary drain will be considered
Beschreibung

Mastectomy | Drain device Axilla

Datentyp

boolean

Alias
UMLS CUI [1]
C0024881
UMLS CUI [2,1]
C0180499
UMLS CUI [2,2]
C0004454
prior axillary dissection (except prior sentinel node procedure)
Beschreibung

Excision of axillary lymph nodes Previous | Sentinel Lymph Node Biopsy Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0193867
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0796693
UMLS CUI [2,2]
C0205156
prior axillary radiotherapy
Beschreibung

Previous Therapeutic radiology procedure Axilla

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0004454
psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out qol forms
Beschreibung

Mental disorders Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry
Beschreibung

Study Subject Participation Status | Therapeutic procedure Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0013230
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Ähnliche Modelle

Eligibility Breast Cancer NCT02311543

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Registration
Item
at registration
boolean
C1514821 (UMLS CUI [1])
Informed Consent
Item
patient has given written informed consent before registration
boolean
C0021430 (UMLS CUI [1])
Gender | Excision of axillary lymph nodes | Sentinel Lymph Node Frozen Sections
Item
female patients; eligible for primary alnd or sentinel lymph node procedure with frozen section and either:
boolean
C0079399 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
C1522495 (UMLS CUI [3,1])
C0016741 (UMLS CUI [3,2])
Newly Diagnosed
Item
newly diagnosed
boolean
C1518321 (UMLS CUI [1])
Breast Carcinoma | Female breast | Entire chest wall | Axilla
Item
or recurrent breast cancer in the conserved breast, chest wall or axilla
boolean
C0678222 (UMLS CUI [1])
C0222603 (UMLS CUI [2])
C1279035 (UMLS CUI [3])
C0004454 (UMLS CUI [4])
Breast Carcinoma | UICC (tumor staging) | AJCC tumor staging
Item
patients with histo- or cytology proven breast cancer uicc/ajcc stage i-iii
boolean
C0678222 (UMLS CUI [1])
C0441914 (UMLS CUI [2])
C0441915 (UMLS CUI [3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Able to speak fluently German language | Able to speak fluently French language | Able to speak fluently Italian language | Able to speak fluently Spanish Language | Able to speak fluently Turkish language | Able to speak fluently English Language
Item
fluency in either german, french, italian, spanish, turkish or english
boolean
C0564241 (UMLS CUI [1,1])
C0017477 (UMLS CUI [1,2])
C0564241 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
C0564241 (UMLS CUI [3,1])
C0022275 (UMLS CUI [3,2])
C0564241 (UMLS CUI [4,1])
C0037750 (UMLS CUI [4,2])
C0564241 (UMLS CUI [5,1])
C0041402 (UMLS CUI [5,2])
C0564241 (UMLS CUI [6,1])
C0376245 (UMLS CUI [6,2])
EuroQoL five dimension questionnaire Complete
Item
the eq-5d questionnaire has been completed at registration
boolean
C2733251 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Pregnancy | Operative Surgical Procedures
Item
patient with child-bearing potential, willing to use effective contraception, not currently pregnant and agreeing not to become pregnant after trial registration and during the 24 weeks after surgery
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Pregnancy test negative Childbearing Potential
Item
a negative pregnancy test within 14 days prior to inclusion is available for all women with child-bearing potential
boolean
C0427780 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Inclusion | Randomization
Item
inclusion criteria at randomization
boolean
C1512693 (UMLS CUI [1])
C0034656 (UMLS CUI [2])
Excision of axillary lymph nodes Indicated | Breast-Conserving Surgery
Item
alnd indicated according to clinical standards, either as single procedure or in combination with breast conserving surgery
boolean
C0193867 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
C0917927 (UMLS CUI [2])
Exclusion Criteria | Registration
Item
exclusion criteria at registration:
boolean
C0680251 (UMLS CUI [1])
C1514821 (UMLS CUI [2])
Hypersensitivity TachoSil | Hypersensitivity Fibrin Tissue Adhesive
Item
known hypersensitivity for tachosil® or fibrin sealant
boolean
C0020517 (UMLS CUI [1,1])
C1871272 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0016004 (UMLS CUI [2,2])
Mastectomy | Drain device Axilla
Item
patients with mastectomy (simultaneously or within 1 month before registration); patients undergoing completion mastectomy at a later day will remain eligible and are evaluable for analysis according to intention to treat. if the axillary drain is still in place at the time of completion mastectomy and a separate drain is inserted underneath the skin flaps, only the axillary drain will be considered
boolean
C0024881 (UMLS CUI [1])
C0180499 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
Excision of axillary lymph nodes Previous | Sentinel Lymph Node Biopsy Previous
Item
prior axillary dissection (except prior sentinel node procedure)
boolean
C0193867 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0796693 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Previous Therapeutic radiology procedure Axilla
Item
prior axillary radiotherapy
boolean
C0205156 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0004454 (UMLS CUI [1,3])
Mental disorders Compliance behavior Limited
Item
psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out qol forms
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Study Subject Participation Status | Therapeutic procedure Investigational New Drugs
Item
concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
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